WASHINGTON – Citing as their prime evidence Sanofi's strategy to prevent approval of Lovenox biosimilars, two senators are building a case for more disclosure of biopharma's financial ties with nonprofit medical groups, especially when those nonprofits intervene on drug approvals and safety issues.
As soon as the bell rang Monday with the FDA's approval of Incivek as the next hepatitis C contender, Vertex Pharmaceutical Inc. was ready to throw some punches to claim its share of the market.
WASHINGTON – Threats of terrorist attacks in the wake of the death of Osama bin Laden and the reality of immense natural disasters are creating a sense of urgency as government officials recognize that the U.S. is "woefully behind" in its capability to rapidly produce vaccines and develop medical countermeasures (MCM).
WASHINGTON – Google searches and all the chatter on social networking sites could become part of the adverse event analyses the FDA uses to gauge the safety of drugs and biologics once they're on the market.
Global in perspective, Aeras, a nonprofit product development partnership (PDP), is singular in its focus – developing the first new preventive tuberculosis (TB) vaccines in nearly a century.
RxBio Inc. has been hard at work building the funding bridge it's counting on to take its lead candidate, RX100, down the home stretch toward approval.
News of Friday's FDA approval of Merck & Co. Inc.'s Victrelis as the first new hepatitis C drug in more than a decade is being overshadowed by the impending approval of the next in line, Vertex Pharmaceutical Inc.'s Incivek.
Biopharma is often the scapegoat for the escalating cost of healthcare, especially when it comes to the price of brand drugs. But since it’s hard to put a price on health and a long life, what gets lost in this focus on the bottom line is the public return on investment (ROI). National Institutes of Health (NIH) Director Francis Collins made that case last week when he testified before a Senate appropriations subcommittee. “Due in large measure to NIH research [and better treatment], our nation has gained about one year of longevity every six years since 1990,” he said. But...
WASHINGTON – As the clock ticks down on the May 31 expiration of the Small Business Innovation Research (SBIR) program, the Senate is considering yet another continuing resolution to keep the program running while Congress tries to hammer out the details of a multiyear reauthorization.
